Ketohexokinase Inhibition in NAFLD

NCT05463575 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-01-24

No results posted yet for this study

Summary

Fructose is a big contributor to the development of non-alcoholic fatty liver disease (NAFLD). Inhibiting ketohexokinase (KHK), the enzyme catalyzing the first committed step in fructose metabolism, is thought to reduced intrahepatic lipid (IHL) content. Pharmacological inhibition of KHK resulted in a decrease in IHL content in NAFLD patients, but additional health effects are still unknown. In this study the investigators aim to look at additional health effects following KHK inhibition (KHKi).

Conditions

  • NAFLD

Interventions

DRUG

Ketohexokinase inhibition

participants will be asked to take 300 mg of the KHKi in tablet form daily for 6 weeks in either period 1 or 2.

OTHER

Placebo

participants will be asked to take 300 mg of the placebo in tablet form daily for 6 weeks in either period 1 or period 2.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY
  • Maastricht University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-11-24
Completion
2023-11-24

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05463575 on ClinicalTrials.gov